NCT07483255 · Darren Orbach
A Phase II Trial of Fetal Embolization for Vein of Galen Malformation
What this study is about
This is a forward-looking, single-treatment group$1 non-randomly assigned interventional study of fetuses to assess the effectiveness and safety of fetal embolization of VOGM. Subjects will receive a one-time study intervention of fetal embolization, at or after 34 weeks of gestation.
View original scientific description
This is a prospective, single-arm non-randomized interventional study of fetuses to assess the efficacy and safety of fetal embolization of VOGM. Subjects will receive a one-time study intervention of fetal embolization, at or after 34 weeks of gestation. After delivery, neurological assessments will be performed every 6 months for 2 years (adjusted for gestational age). Data will be compared to historical cohorts.
Interventions
DEVICE
Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils
The study involves a single fetal intervention of maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization. Detachable platinum coils (Target XL and XXL Detachable Coil, Stryker Neurovascular) will be used to pack the prosencephalic varix.
Primary outcome measures
Efficacy of fetal embolization for patients with vein of Galen malformations
Time frame: Birth to day 30 of life
Primary outcome/endpoint: mortality measured from birth to day 30 of life.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Pregnant woman carrying a fetus harboring a vein of Galen malformation in whom the straight sinus or falcine sinus draining the prosencephalic varix measures 7 mm or more on fetal MRI (medio-lateral diameter measured at the narrowest point of the sinus along the rostral-caudal axis, assessed on a T2-weighted coronal or axial slice).
- Fetal gestational age of 34 weeks or more at the time of the planned fetal intervention, as determined by clinical information and evaluation of first ultrasound. The suitability for fetal treatment, in terms of technical/positional factors, will be assessed on a case-by-case basis by the MFM, ultrasonographer, and neurointerventionalist participating in the study.
- Anatomic diagnosis of fetal vein of Galen malformation. Various cerebrovascular conditions, such as dural sinus malformation and pial arteriovenous fistula, can result in dilated intracranial vascular structures being visualized in utero. Similarly, fetal dilatation of the vein of Galen can occasionally be seen without the presence of an arteriovenous lesion at all, as a benign venous variant. This condition is readily distinguishable sonographically from VOGM by virtue of the presence of dilated arterial feeding pedicles, and by the presence of an arterial waveform within the varix. This study is aimed solely at fetuses with an established diagnosis of vein of Galen malformation.
Exclusion criteria
- Extensive fetal brain parenchymal injury/gliosis, i.e. \>10% of supratentorial brain volume (SFP presentation). In some cases, significant bihemispheric cerebral parenchymal injuries are seen at the time of initial fetal diagnosis of vein of Galen malformation (SFP cohort). Such fetuses rarely survive, but if they do, are profoundly neurodevelopmentally impaired: typically blind, mute, quadriparetic, often with unremitting intractable seizures, and permanently bed-bound and uncommunicative. As there is no realistic possibility of achieving a good neurological outcome in such patients, fetuses with diffuse bihemispheric brain injury will be excluded.
- Irreversible fetal non-brain organ injury (e.g. hydrops fetalis as a manifestation of heart failure, a finding which portends fatal outcome in fetuses with vein of Galen malformation).
- Fetus with VOGM in whom the straight sinus or falcine sinus draining the prosencephalic varix measures less than 7 mm on fetal MRI (T2-weighted coronal or axial slice, medio-lateral diameter measured at the narrowest point of the sinus along the anterior-posterior axis), fitting fetal MRI criteria for likely evolution into the IT cohort
- Severe maternal obesity pre-pregnancy as defined by body mass index (BMI) of 40 or greater
- Fetuses with major extracranial congenital anomalies
- Evidence of preterm labor, rupture of membranes or abruption
- Maternal coagulopathy: INR \> 1.2; PT/PTT above normal ranges for the lab; platelets \<100
- Any maternal use of anticoagulants, whether prophylactic or therapeutic.
- Prior maternal medical history that would preclude epidural anesthesia
- Multi-fetal pregnancy
- Placenta previa or accreta
- Participation in another fetal study that influences maternal and fetal morbidity and mortality
- Known maternal hypersensitivity to 316LM stainless steel
- Supine hypotensive syndrome
Where
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 23, 2026 · Source of record for eligibility and locations